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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 6, 2008 | ||||
| Last Updated Date | May 6, 2008 | ||||
| Start Date ICMJE | January 2005 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improve physical activity and dietary behaviors among sedentary patients [ Time Frame: annually x 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin. [ Time Frame: annually x 3 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Changing Healthy Outcomes In Clinic Environments | ||||
| Official Title ICMJE | Health Promotion Intervention: Sedentary Primary Care Patients | ||||
| Brief Summary | This study will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits. The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician. The health goals for subjects in this study are: 1) increase physical activity to 30 minutes each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat to a healthy level. |
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| Detailed Description | The benefits of physical activity and proper nutrition have been well established to prevent and reduce the devastating effects of chronic illness including, cardiovascular disease, diabetes, and obesity. Unfortunately, nearly 80% of individuals fail to get enough exercise and eat a proper diet to alter these health disorders. In the United States, physicians do not routinely counsel patients about physical activity and nutrition. Although few studies have examined promotion of physical activity in the primary care setting, most have been disappointing. Achieving and maintaining healthy behaviors remain a major challenge to promoting health and caring for illness. This research proposals aims are to a) evaluate two health behavior change intervention strategies to improve physical activity and dietary behaviors among sedentary patients in a primary care office; and b) assess by cost-benefit analysis, the impact of each model intervention. After initial recruitment from OHSU Internal Medicine and Family Practice clinics, 105 sedentary patients will be randomly assigned to Model 1, Model 2, or Model 3. Model #1, a one-on-one, individualized counseling intervention known as Motivational Interviewing, based on the transtheoretical model of behavior change, will use twelve health educator counseling meetings and ten bi-weekly follow-up phone calls the first year and six 60-minute sessions will occur in the second year of the intervention. Model #2, a team-centered intervention where the health promotion curriculum is delivered by a group facilitator to a team of patients (based on the social influence theory) consists of twelve 60-minute peer facilitated group meetings and ten follow-up phone calls, with six sessions occurring the second year of the full outcome study. Group facilitators will be trained and use scripted lesson plans. Model #3, a usual practice control condition (5 minute physician advice using the Physician Advice Counseling Exercise or PACE format). Models 1 and 2 contact hours are the same. Year 01 is the pilot study to revise and refine the curriculum and study protocol. The full intervention will last two years while the behavior change durability will be assessed over another full year. The study's primary outcomes are increased physical activity as measured by peak oxygen uptake and survey, dietary changes assessed by intake survey, and body composition changes as measured by DEXA. Secondary outcome measures include blood pressure lipid and lipoprotein levels, biochemical markers of inflammation (CRP) and hormonal markers of obesity. Outcomes will be assessed using repeated measures design. Relationships among mediators, the intervention, and the outcome measures will be identified. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2009 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00674518 | ||||
| Responsible Party | Kerry Kuehl, MD DrPH, Oregon Health & Science University | ||||
| Study ID Numbers ICMJE | 1-K23-RR017554-01A2 | ||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||
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| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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